Friday, January 23, 2015

As many MS patients are aware, stem cells represent one of the great hopes for vanquishing multiple sclerosis by way of their tantalizing potential for repairing damaged brain and spinal cord tissues, regulating aberrant immune responses, and ultimately restoring patients to good health. Research into the use of stem cells to treat a wide variety of diseases is increasing seemingly by the day, and scientists are beginning to unlock the tremendous promise of these emerging therapies. The therapeutic use of stem cells may dramatically transform the medical landscape in the coming years, and this prospect provides much-needed hope to patients desperately searching for answers.

Sadly, where there are significant populations of desperate people, there are almost always human sharks ready, willing, and able to take advantage of them. Thus, it seems, we have the story of Regenetek, a Canadian company that arranged for patients to travel to India for an experimental stem cell treatment under the guise of a certified medical clinical trial. Over the last several weeks, the Canadian press has revealed that the man behind Regenetek, Mr. Doug Broeska, allegedly misrepresented his credentials, the qualifications and abilities of his company to conduct a valid medical clinical study, and cajoled, bullied, and berated patients who dared question his authority or the veracity of his claims (click here). It must be said that while some of the patients who underwent the Regenetek’s stem cell therapy in India received no benefit, others have reported good results, and that’s where this story gets tricky. Though Regenetek and Doug Broeska may turn out to be complete shams, the stem cell therapy the company was hawking may have value, at least according to patients who claim to have seen benefit from it (click here).

I first became aware of Regenetek when Mr. Broeska invited me via email to join Regenetek’s private Facebook group, where patients discussed various aspects of the company’s stem cell treatment and their experiences with it. At that time, Broeska was known as Dr. Doug Broeska, or “Dr. Doug”, claiming that he was a “PhD medical researcher”. That rather generic designation set off a few red flags in my mind, especially after a quick Google search revealed little other than the fact that Mr. Broeska had been involved in some sort of electronic medical records company before taking an apparently rather sudden interest in stem cells.

Further red flags sprung up when, after spending a little time on his Facebook page, I saw that Broeska was posting articles he had written on various stem cell related subjects that contained errors and misinformation. These articles were also posted on Regenetek’s website and blog. One article in particular raised my cackles, a piece about HSCT – a type of stem cell therapy in which a patient’s immune system is ablated using chemotherapy drugs and then rebooted through the use of bone marrow derived stem cells, which clinical trials are proving to be quite effective in properly selected patients – that was so ill-conceived that I felt compelled to call out the myriad inaccuracies in the piece. After a bit of back-and-forth, Broeska removed the article, but his seeming intentional misrepresentations of fact set off alarm bells of doubt in me about his credibility.

As I’ve mentioned in the past, I’m not a huge fan of Facebook, and after the above incident I didn’t spend much time visiting the Regenetek page. I was left with questions about the clinical trial the company was supposedly conducting, since it seemed that the only follow-up being done after patients returned from India were e-mailed anecdotal patient self-reports of how they were doing post treatment (no MRIs, neurologic testing, or other objective measures required), as well as doubts about many of the statements and claims made by “Dr. Doug”, but I’d seen how anybody raising such concerns on the site were met with hostility and frankly wanted no part of it. I remained in email contact with one of the members of the group, who occasionally asked for my opinion on stem cell related topics and told me about several disgruntled patients, but other than that I didn’t give Regenetek or Mr. Broeska much thought at all.

A few weeks ago I was alerted to the fact that the Regenetek Facebook site and related webpages had been taken down, along with Doug Broeska’s business profiles on the LinkedIn website. Soon after, an article appeared in the Winnipeg Free Press detailing Mr. Broeska’s alleged web of deceit (click here). Among the article’s findings were that “Dr. Doug’s” claims of earning a PhD at the University of Manitoba could not be confirmed (the University had no record of his graduating), and that another of his claimed degrees came from an institution called Brightland University, which apparently doesn’t actually exist, and is only part of the University Degree Program, an online degree mill that operates dozens of sham institutions. Furthermore, Broeska had claimed that he was a member of the International Cellular Medicine Society (click here), an international stem cell research oversight organization, but the executive director of the ICMS could find no evidence of Broeska’s membership. It had also been claimed that Regenetek’s clinical trial was being run under the direction of several Institutional Review Boards (IRB’s), which are governing bodies that ensure the validity of medical research efforts. No record of any legitimate IRB approvals could be found, and one of the organizations cited by Broeska as overseeing the Regenetek clinical trial was found to be headed up by one of his business partners.

Additionally, Broeska often boasted that Regenetek was a not-for-profit corporation, and that the company actually helped subsidize the cost of patients' treatments, for which the patients themselves paid up to $45,000 US. While Regenetek is indeed registered with Canada as a not-for-profit entity, most of the patients sent for stem cell treatment in India paid their fees to another Broeska owned company, CliniCard, which is a for-profit corporation (click here). Allegations have also been made that Regenetek paid patients that had gone through their stem cell protocol to recruit other patients, and to post testimonials and videos on Facebook and YouTube.

Perhaps worse than all of Broeska’s alleged falsehoods and financial sleight-of-hand were his practices involving many of the patients with whom he dealt (click here and here). According to reports, patients were threatened with being kicked out of the Regenetek clinical trial if they questioned any of the claims or methodologies used by Broeska after they returned from India. Broeska repeatedly stated that virtually all patients undergoing the treatment protocol in India saw “curative effects”, and that many had “returned to complete health without symptoms” (click here). Patients who reported little or no benefit from the treatment were accused of working for competitors, or otherwise having ulterior motives, and were booted out of the Regenetek study. Upon returning home, most patients received little if any follow-up, despite their supposedly enrollment in an ongoing clinical trial. Broeska was known to spend hours emailing and even Skypeing with prospective clients, befriending them in an effort to convince them of the validity of his claims and of his expertise in stem cell research, and ultimately to sign them up for treatment in India, to the tune of tens of thousands of dollars.

Regenetek partnered with an Indian firm called Genesis, whose Chief Operating Officer is an IT professional named Surjo Banerjee, that oversaw the medical procedures performed at a hospital in Pune, India. As previously stated, patients were charged up to $45,000 US for treatment (not including travel expenses), which consisted of CCSVI angioplasty combined with an infusion of stem cells derived from the patient’s bone marrow, in addition to intravenous and intrathecal (spinal) infusions of these same autologous mesenchymal stem cells. While in India, patients also underwent roughly 2 hours of physical therapy each day, purportedly to help the stem cells circulate to where they were needed. Perhaps not coincidentally, studies have shown that periods of intense physical therapy alone can markedly improved the functionality of many MS patienes, although the benefits fade after physical therapy is stopped (click here). Many of the claims and methodology used in what Regenetek dubbed the CTP (Combination Treatment Protocol) have been challenged by doctors familiar with stem cell technology (click here).

Due to the fact that so little actual follow-up was done on the approximately 70 patients who traveled to India for treatment, it’s impossible to quantify the actual effects of the treatment; suffice it to say that of the relatively few patients who have been heard from there are some who say they have seen sometimes dramatic improvement, and others who claim the CTP treatment to be a total failure. It’s impossible to objectively judge the veracity of subjective anecdotal patient reports, as any number of factors could contribute to the self-reported success or failure of any experimental medical procedure.

I will say by all accounts it does appear that Regenetek patients did receive some sort of stem cell therapy from licensed doctors while in India, effective or not; the scam that occurred lies mostly in the manner by which patients were recruited and then handled after they returned home, and in the financial shenanigans allegedly undertaken by Mr. Broeska and his colleagues. Unfortunately, because of the lack of any rigorous follow-up whatsoever, the actual effects of the treatment on the 70 or so patients who underwent the stem cell therapy will never be known, at least in any scientifically valid fashion. This is a real shame, for who knows what valuable lessons might have been learned if these patients had been properly assessed post treatment by qualified medical professionals?

As of this writing, the Indian company Genesis, which worked hand-in-hand with Regenetek until news of this scandal broke, is planning to continue offering stem cell treatments in India (at a cost of $16,050 US, as compared to the $45,000 charged by Regenetek), and even has plans to open a clinic in Trinidad despite the questions surrounding its offerings (click here). Patients who paid deposits to Regenetek but have not yet gone to India are demanding refunds, but thus far have had very little success getting any response. Posts have appeared on Facebook pages on which this matter has been discussed stating that representatives from Genesis or Regenetek will not be answering any inquiries posed on those sites. A Canadian doctor who worked closely with Regenetek has claimed she was “scammed” (click here). It seems that most of the players involved are now in serious “cover your ass” mode, and investigations into Regenetek by the Royal Canadian Mounted Police and other Canadian government agencies are now underway.

If any or all of the allegations made about Regenetek hold true, I hope all who read this will see this story as a cautionary tale about the dangers lurking in some corners of the world of alternative medicine. Distressingly, there are living, breathing human beings out there who somehow feel no guilt in taking advantage of desperate people with horrible illnesses. Back in high school I took an art appreciation class, most of whose content I don’t remember. I do remember, though, something that my art teacher, Mr. Rosen, once said: “Be careful, there’s human garbage out there…” Don't ask me what that quote had to do with art appreciation, but it sure was memorable, and quite apropos of charlatans who seek to profit from the desperation of sick people.

Friday, January 9, 2015

Well, if you’re listening, I think there’s been a terrible mistake. You see, I’ve got this, well, this creeping paralysis, and it just won’t stop creeping… and creeping… and creeping. It’s creeping so much that it’s creeping me out, and I’m afraid it’s about to swallow me. So, before things get completely out of hand, I’d like to lodge a formal complaint and see if I can get some kind of a cosmic credit, or even maybe a do-over. You know, like back in the schoolyard, when in the middle of a game something would go wrong and all the kids would agree to just wipe the slate clean, and make believe that whatever happened never happened. Do you think we could work something out along those lines? A do-over? Just one?

The department store Nordstrom is famous for taking back almost any item, even if it’s been used, and I’m thinking I must be due some kind of refund or other form of galactic recompense. I mean, if Nordstrom can do it, certainly you, a universe filled with multiple dimensions and all kinds of crazy quarks and pulsars and quasars, must have some way of correcting what has obviously been a royal screwup. No, I don’t have a receipt, but I do have a birth certificate and an expired driver’s license, will that do?

Because, really, I’m pretty sure this isn’t the way things were meant to play out. I’m fairly certain that somewhere along the line the story of my life has gone way off script, like in one of those old movies where somebody accidentally picks up the wrong suitcase at an airport or train station and their fates get switched with the person who picked up their suitcase, and all sorts of wackiness then ensues. I’m positive that somehow my cosmic suitcase got switched, and I’m not at all happy with the ensuing wackiness.

When I was younger, I had a preview reel of what my life would be like running through my head, and I’m certain that literally feeling sick and tired all of the time while becoming ever increasingly paralyzed wasn’t in any of the selected scenes playing on an endless loop in my noggin. I was going to be a famous writer, rock star, or movie director, and my life was supposed to be filled with all kinds of exciting escapades and adventures, with just enough drama thrown in to make things interesting. I wasn't expecting a fairytale, but the screen in my head wasn’t showing a disaster flick, either.

Yes, yes, I know, all of that might seem ridiculous and downright juvenile, but I never claimed to be the paragon of maturity. After all, you’re only young once but you can be immature forever, right? And yeah, I’m well aware that almost no one’s youthful dreams ever really come true, but I never ever imagined that dreams could so easily turn into nightmares. Looking back I’ll admit that I didn’t always make the best choices, and probably made more than my share of mistakes, but surely I never did anything bad enough to deserve this, did I?

I mean, I just watched a television interview with the serial killer Son of Sam, who slaughtered six people and terrorized New York City for months on end back when I was a teenager, and he looked healthy as a horse sitting there in prison. Doesn’t he deserve a nice dose of creeping paralysis? Or how about the monsters who rape or hurt children, or plot horrific terrorist attacks that kill dozens or hundreds of people? I see them on the news all the time, looking all hale and hearty. How about a liberal sprinkling of progressive multiple sclerosis for them?

Believe me, you don’t have to tell me that I’m no saint, but even with all of my missteps and blunders and mistakes, the person I hurt worst of all most often seems to have been myself. Being sick has given me all kinds of time to look back and analyze my past, and at this point I think my regrets have regrets. I’d love to be able to use some of the insights all of this introspection has given me to live a more worthy life and forge a future free of the dunderheaded moves of my past, but the way things are heading if I think too much about my future I might just poop in my pants. As a matter of fact, without being granted a cosmic refund or credit or do-over, pooping in my pants could very well be a large part of my future. Gross. And things could very well only go downhill from there.

I’ll admit that getting sick hasn’t been all bad, and in some ways it’s given me freedoms that I probably otherwise never would have realized. I was able to stop working and start writing, which is probably what I should have been doing all along. Before this creeping paralysis crept so far I was able to take lots of photos and videos from my wheelchair, fulfilling creative impulses I’d long dreamt of indulging (without the wheelchair part), but I’m afraid those days are probably over. I sure have learned a heckuva lot and met all kinds of interesting people, many of them fellow patients, most of whom, FYI, also don’t deserve the crap they’ve been slapped with. It would be nice, Mr. or Mrs. Cosmos, if you could find a way to cut them more than a little slack, too. I’ve discovered emotional and physical resources within myself that I didn’t know existed, which has been kind of cool. But now things are getting pretty dicey, and I think I’ve squeezed all the positives out of this experience that there are to be squeezed. In all honesty, I’m getting scared. Really, really scared.

So what do you say? Can you give a brother a break? How about this: forget about making me better, just stop me from getting any worse, okay? Certainly not the ideal situation from my perspective, but I’ll take it. How’s that for a compromise? See, I’m reasonable, not like all those asshats in Washington. Can’t we work something out? A little give-and-take? I’m not sure I have all that much left to give, but I’m open to suggestions. I’ll be right here waiting for your answer, just a pimple on a flea’s ass in this ever-expanding universe, but I trust that you’ll know where to find me.

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Regretfully, due to the high volume of e-mail received and the realities of living with progressive MS, I'll no longer be able to respond to all e-mails sent. I do read each note, and will do my best to answer as many messages as I can.

About Me

I'm Marc, a 53-year-old male, living in New York City with my lovely and wonderful wife Karen. Diagnosed with Primary Progressive Multiple Sclerosis in March of 2003, I now require a wheelchair to get around the city. I like to drive the wheelchair at full speed, thus the moniker "Wheelchair Kamikaze". I've managed to rig a camera to my chair, so I'm able to take videos and still photos from the unique vantage point of a wheelchair, which I intend to post here.
Before getting sick, I was the Director of DVD Production for one of the major international music companies. Yes, I was once a member of the Evil Empire...
Prior to my enlistment in the Evil Empire, I worked as a video producer and editor.
I grew up in New York City, and spent the 1980s in Boston (college and postcollege rock 'n roll craziness). During the 1990s, I lived in South Florida, until I woke up one morning and realized I was living in South Florida, came to my senses, and moved back to New York.
I hope you like my blog...